FDA.reportPublic FDA data

Signature ONE Software Package

Primary DI
00889024585393
Brand
Signature ONE Software Package
Company
Orthosoft Inc
Model
302.4018
Catalog number
302.4018
Device description
v. 1.0
Published
2022-07-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
MBFProsthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
PHXShoulder Prosthesis, Reverse Configuration
QHEShoulder Arthroplasty Implantation System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedOrthopedic2
KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer CementedOrthopedic2
MBFProsthesis, Shoulder, Semi-Constrained, Metal/Polymer, UncementedOrthopedic2
PHXShoulder Prosthesis, Reverse ConfigurationOrthopedic2
QHEShoulder Arthroplasty Implantation SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190595000
K192074000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190595000Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)2019-06-05KWT
K192074000Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)2019-08-30QHE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024585393PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024585393008890245853938890245853930889024585393

GMDN Terms#

Term, Definition table
TermDefinition
Radiology DICOM image processing application softwareA software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/ disc burning) and/or image manipulation and quantification (e.g., non-interpretive graphical overlays).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
205670032
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024707047Signature ONE Software Package302.4018302.40182026-07-10
00887868552120ROSA®20-8020-158-0020-8020-158-002023-04-10
00887868558146ROSA® Shoulder20-8087-302-00208087302002024-03-06
00887868580963ROSA® Shoulder20-8087-506-00208087506002024-03-06
00887868554391Signature™ Comprehensive®20-8090-009-0120-8090-009-012024-02-09
00887868554407Signature™ Comprehensive®20-8090-009-0220-8090-009-022024-02-09
00887868552205ROSA® Knee20-8020-191-0020-8020-191-002022-10-20
00889024563636Sesamoid ®20-8000-000-1120-8000-000-112021-01-28
00889024304079Trabecular Metal20-8075-004-0220-8075-004-022016-09-12
00889024304307ROSA® Robotics20-8000-010-0620-8000-010-062016-09-07
00889024304406ROSA® Robotics20-8000-010-1720-8000-010-172016-09-07
00889024304413Optical20-8000-010-1820-8000-010-182016-09-12
00889024304567ROSA® Robotics20-8000-010-3320-8000-010-332016-09-12
00889024304871Optical20-8000-020-1320-8000-020-132016-09-12
00889024304895Optical20-8000-020-1520-8000-020-152016-09-12
00889024304956Optical20-8000-020-2120-8000-020-212016-09-12
00889024305397iASSIST20-8011-040-0020-8011-040-002016-09-07
00889024305748Signature ONE20-8070-009-002017-06-13
00889024305762PSI Knee20-8070-010-022017-09-28
00889024486638X-PSI™20-8085-020-0020-8085-020-002018-04-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840097503677Veritas InstrumentationRestor3d, Inc.PHX2026-10-16
00889024707047Signature ONE Software PackageOrthosoft IncKWS2026-07-10
00889024707047Signature ONE Software PackageOrthosoft IncQHE2026-07-10
00889024707047Signature ONE Software PackageOrthosoft IncMBF2026-07-10
00889024707047Signature ONE Software PackageOrthosoft IncKWT2026-07-10
00889024707047Signature ONE Software PackageOrthosoft IncPHX2026-07-10
00887868554391Signature™ Comprehensive®Orthosoft IncPHX2024-02-09
00887868554391Signature™ Comprehensive®Orthosoft IncQHE2024-02-09
00887868554391Signature™ Comprehensive®Orthosoft IncKWS2024-02-09
00887868554391Signature™ Comprehensive®Orthosoft IncMBF2024-02-09
00887868554391Signature™ Comprehensive®Orthosoft IncKWT2024-02-09
00887868554407Signature™ Comprehensive®Orthosoft IncPHX2024-02-09
00887868554407Signature™ Comprehensive®Orthosoft IncMBF2024-02-09
00887868554407Signature™ Comprehensive®Orthosoft IncQHE2024-02-09
00887868554407Signature™ Comprehensive®Orthosoft IncKWS2024-02-09
00887868554407Signature™ Comprehensive®Orthosoft IncKWT2024-02-09
00887868522987Signature ONEOrthosoft IncMBF2022-07-20
00887868522987Signature ONEOrthosoft IncKWT2022-07-20
00887868522987Signature ONEOrthosoft IncKWS2022-07-20
00887868522987Signature ONEOrthosoft IncPHX2022-07-20
00887868522987Signature ONEOrthosoft IncQHE2022-07-20
00887868522994Signature ONEOrthosoft IncMBF2022-07-20
00887868522994Signature ONEOrthosoft IncQHE2022-07-20
00887868522994Signature ONEOrthosoft IncPHX2022-07-20
00887868522994Signature ONEOrthosoft IncKWT2022-07-20
00887868522994Signature ONEOrthosoft IncKWS2022-07-20
00889024647046Signature ONE Software PackageOrthosoft IncPHX2022-07-05
00889024647046Signature ONE Software PackageOrthosoft IncMBF2022-07-05
00889024647046Signature ONE Software PackageOrthosoft IncKWS2022-07-05
00889024647046Signature ONE Software PackageOrthosoft IncQHE2022-07-05